Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery

Cataract Clinical Trial

Official title:

Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Laser Refractive Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04522427
• Other study ID #: Yinghong Ji
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2020
• Source: Eye & ENT Hospital of Fudan University
• Contact: Yinghong Ji, phD
• Phone: 18917785069
• Email: jiyh_eent[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, randomized, open, positive product, parallel controlled trial to evaluate the clinical outcomes of presbyopia-correcting intraocular lenses(IOLs) in eyes with previous corneal refractive surgery.

Specific Aim 1 (Primary): To compare the surgical successful rate of Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.

Specific Aim 2 (Secondary): To study the suboptimal surgical outcomes between Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.

Description:

Recently, the demands for myopia correction and corneal refractive laser surgery are rising with the increased prevalence of myopia. Corneal laser refractive surgery includes photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), laser-assisted subepithelial keratomileusis ( LASEK), femtosecond assisted laser in situ keratomileusis (FS-LASIK), and small incision lenticule extraction(SMILE). At present, FS-LASIK and SMILE are the mainstream methods for correcting myopia refractive surgery with advantages of safety, reliability, predictability and stability compared with other types of refractive surgery. Cataract is the most important cause of blindness in my country and even in the world. More than 50% of blind people are caused by cataract. Many patients who have undergone corneal laser refractive surgery may develop presbyopia or cataracts with age. Phacoemulsification and intraocular lens(IOLs) implantation are the main methods for cataract due to lacking effective pharmaceutical treatments. In addition, the patients who use traditional monofocal IOLs without the ability of accommodation may fail to get rid of glasses. Therefore, a solution that can provide both distance vision and near vision is needed to the presbyopia or cataracts patients with previous corneal refractive surgery and accustomed to taking glasses off.The application of presbyopic IOL in cataract after corneal refractive surgery become extensive with the IOL technology continuously advancing, including Extended Depth-of-Focus(EDOF) IOL, multifocal IOL(especially trifocal IOL) and so on, which can improve the distance, middle, and near visual acuity conducing to reduce the rate of wearing glasses after cataract surgery.

This project is a single-center, randomized, open, positive product, parallel controlled trial to study the clinical outcomes and applied value of presbyopic IOLs, including EDOF and trifocal IOLs after corneal laser refractive surgery complicated with cataracts, and seek better solutions to enable patients to achieve satisfactory visual quality and refractive results after surgery, culminating in completing patients' demand of taking glasses off.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The operated eye has ever undergone corneal refractive surgery, including PRK, LASIK, LASEK, FS-LASIK, SMILE and excluding RK

• At least one eye suffering from cataract and expected to undergo phacoemulsification and IOL implantation and cataract nuclei rigidity in the operated eye from 1 to 3 degree

• Expected to use intraocular lens power in -10.0D~+30.0D

• Willing and able to comply with scheduled visits and other study procedures.

• The need to decrease the dependence of glasses

• Signing an informed consent form

Exclusion Criteria:

• Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential

• Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)

• The density of corneal endothelial cells is lower than 2000/mm2

• The natural diameter of the pupil under the darkroom is less than 3mm or greater than 5.5mm

• The Kappa or Alpha angle of the operated eye is greater than 0.5mm, or the Kappa angle is greater than half of the diameter of the central refractive optical zone in the multifocal intraocular lens

• Patients with expected best corrected distance visual acuity(BCDVA) less than 0.5 (decimal vision)

• Occurrence of irregular corneal astigmatism that affects postoperative vision

• Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye

• Pregnant, lactation or planning to become pregnant in the near future

• Any surgical contraindications

• Uncontrolled systemic or ocular disease

• Use of any systemic or topical drug known to interfere with visual performance

• Other ocular surgery at the time of the cataract extraction

• Traumatic cataract or congenital bilateral cataract in the operated eye

• Getting used to reading with glasses

• High requirements for visual functions in patients' career or daily life

• Professional drivers or frequent outdoor workers at night

• A medical history of photophobia

• Amblyopia

• Excessive vision expectations after surgery or too sensitive, nervous, depressed or picky

• Unsupervised or unable to comply with scheduled visits

• The contralateral eye was judged to lose visual function

• Other situations where the researcher judges that the patient is not suitable for inclusion

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)
IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF
• Use Monofocal intraocular lenses(IOLs)
Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS

Locations

Country	Name	City	State
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (17)

Abulafia A, Hill WE, Koch DD, Wang L, Barrett GD. Accuracy of the Barrett True-K formula for intraocular lens power prediction after laser in situ keratomileusis or photorefractive keratectomy for myopia. J Cataract Refract Surg. 2016 Mar;42(3):363-9. doi: 10.1016/j.jcrs.2015.11.039. Epub 2016 Mar 19. — View Citation

Alio JL, Abdelghany AA, Abdou AA, Maldonado MJ. Cataract surgery on the previous corneal refractive surgery patient. Surv Ophthalmol. 2016 Nov - Dec;61(6):769-777. doi: 10.1016/j.survophthal.2016.07.001. Epub 2016 Jul 15. Review. — View Citation

Aramberri J. Intraocular lens power calculation after corneal refractive surgery: double-K method. J Cataract Refract Surg. 2003 Nov;29(11):2063-8. — View Citation

Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11. Review. — View Citation

Chan TC, Liu D, Yu M, Jhanji V. Longitudinal evaluation of posterior corneal elevation after laser refractive surgery using swept-source optical coherence tomography. Ophthalmology. 2015 Apr;122(4):687-92. doi: 10.1016/j.ophtha.2014.10.011. Epub 2014 Dec 6. — View Citation

Ferreira TB, Pinheiro J, Zabala L, Ribeiro FJ. Comparative analysis of clinical outcomes of a monofocal and an extended-range-of-vision intraocular lens in eyes with previous myopic laser in situ keratomileusis. J Cataract Refract Surg. 2018 Feb;44(2):149-155. doi: 10.1016/j.jcrs.2017.11.007. Epub 2018 Mar 8. — View Citation

Gimbel H, Sun R, Kaye GB. Refractive error in cataract surgery after previous refractive surgery. J Cataract Refract Surg. 2000 Jan;26(1):142-4. — View Citation

Keates RH, Pearce JL, Schneider RT. Clinical results of the multifocal lens. J Cataract Refract Surg. 1987 Sep;13(5):557-60. — View Citation

Koch DD, Wang L. Calculating IOL power in eyes that have had refractive surgery. J Cataract Refract Surg. 2003 Nov;29(11):2039-42. — View Citation

Li M, Li M, Chen Y, Miao H, Yang D, Ni K, Zhou X. Five-year results of small incision lenticule extraction (SMILE) and femtosecond laser LASIK (FS-LASIK) for myopia. Acta Ophthalmol. 2019 May;97(3):e373-e380. doi: 10.1111/aos.14017. Epub 2019 Jan 11. — View Citation

Naseri A, McLeod SD. Cataract surgery after refractive surgery. Curr Opin Ophthalmol. 2010 Jan;21(1):35-8. doi: 10.1097/ICU.0b013e328333e9ab. Review. — View Citation

Seitz B, Langenbucher A, Nguyen NX, Kus MM, Küchle M. Underestimation of intraocular lens power for cataract surgery after myopic photorefractive keratectomy. Ophthalmology. 1999 Apr;106(4):693-702. — View Citation

Tang M, Li Y, Huang D. An intraocular lens power calculation formula based on optical coherence tomography: a pilot study. J Refract Surg. 2010 Jun;26(6):430-7. doi: 10.3928/1081597X-20090710-02. Epub 2010 Jun 17. — View Citation

Tang Y, Wang X, Wang J, Huang W, Gao Y, Luo Y, Lu Y. Prevalence and Causes of Visual Impairment in a Chinese Adult Population: The Taizhou Eye Study. Ophthalmology. 2015 Jul;122(7):1480-8. doi: 10.1016/j.ophtha.2015.03.022. Epub 2015 May 16. — View Citation

Wang L, Hill WE, Koch DD. Evaluation of intraocular lens power prediction methods using the American Society of Cataract and Refractive Surgeons Post-Keratorefractive Intraocular Lens Power Calculator. J Cataract Refract Surg. 2010 Sep;36(9):1466-73. doi: 10.1016/j.jcrs.2010.03.044. — View Citation

Wang L, Tang M, Huang D, Weikert MP, Koch DD. Comparison of Newer Intraocular Lens Power Calculation Methods for Eyes after Corneal Refractive Surgery. Ophthalmology. 2015 Dec;122(12):2443-9. doi: 10.1016/j.ophtha.2015.08.037. Epub 2015 Oct 14. — View Citation

Wen D, McAlinden C, Flitcroft I, Tu R, Wang Q, Alió J, Marshall J, Huang Y, Song B, Hu L, Zhao Y, Zhu S, Gao R, Bao F, Yu A, Yu Y, Lian H, Huang J. Postoperative Efficacy, Predictability, Safety, and Visual Quality of Laser Corneal Refractive Surgery: A Network Meta-analysis. Am J Ophthalmol. 2017 Jun;178:65-78. doi: 10.1016/j.ajo.2017.03.013. Epub 2017 Mar 20. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative UDVA measured with standard visual acuity charts	postoperative uncorrected distance visual acuity(UDVA)	Measured 3 months after cataract surgery
Primary	Postoperative UIVA measured with standard visual acuity charts	Postoperative uncorrected intermediate visual acuity(UIVA)	Measured 3 months after cataract surgery
Primary	Postoperative UNVA measured with standard visual acuity charts	Postoperative uncorrected near visual acuity(UNVA)	Measured 3 months after cataract surgery
Secondary	monocular vision measured with standard visual acuity charts	Uncorrected distance visual acuity and best corrected distance visual acuity	Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
Secondary	monocular vision measured with standard visual acuity charts	Uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity	Measured 1 month, 3 months, and 6 months after cataract surgery
Secondary	Diopter measured by Phorometer	Important factor affecting the improvement of postoperative visual function	Measured 1 month, 3 months, and 6 months after cataract surgery
Secondary	IOL rotation stability	The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)	Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
Secondary	Wavefront aberration measured with the iTrace (Tracey Technologies, Houston, TX)	total aberration, total low-order aberration, and total high-order aberration	Measured 1 month, 3 months, and 6 months after cataract surgery
Secondary	Contrast sensitivity measured by FACT chart	Provide accurate and comprehensive objective basis for the evaluation of visual function of cataract patients	Measured 6 months after cataract surgery
Secondary	Binocular vision measured with standard visual acuity charts	Uncorrected distance visual acuity, best corrected distance visual acuity, uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity.	Measured 6 months after cataract surgery
Secondary	The rate of IOL dislocation	Effectiveness evaluation index	Measured 6 months after cataract surgery
Secondary	Defocus Curve	Drawing Defocus Curve after taking the average of the data collected in each group of patients	Measured 6 months after cataract surgery
Secondary	Postoperative satisfaction:Chinese version visual function index-12(VF-12-CN)	Questionnaire survey on patients' quality of life	Measured 6 months after cataract surgery